ES2883714T3 - Medication delivery device that has a stopper unit - Google Patents

Abstract

A drug delivery device (i) comprising: - a housing (2; 2a) having a proximal end and a distal end; - a medicament container (8) placed in the housing (2; 2a) and having a medicament delivery member protector (6); - a medication supply mechanism associated with the medication container (8); - an activation member (3) operatively connected to the drug delivery mechanism and longitudinally movable relative to the housing from an extended position to a retracted position to activate the drug delivery mechanism; and - a removable plug unit (10) comprising an outer tubular plug body (7; 7a) and an inner tubular integrity locking member (9; 9a) coaxially coupled to the outer tubular plug body; characterized in that in a first position of the removable plug unit (10), a resilient structure (91; 91a) of the inner tubular integrity locking member (9; 9a) is configured to interact with both a first structure (31) attachment of the activation member (3) as with a second attachment structure (21; 21a) of the housing (2; 2a) to prevent the activation member (3) from moving towards the retracted position; wherein the resilient structure (91; 91a) of the inner tubular integrity locking member (9; 9a) comprises a pair of spaced longitudinally extending arms (92; 92a) that are flexible in the transverse direction and that define an opening (93; 93a) with each other.

Description

DESCRIPTION

Medication delivery device having a cap unit

technical field

The present description refers generally to drug delivery devices. In particular, it relates to a drug delivery device having a removable cap unit that prevents the drug delivery device from being accidentally activated and prevents recapping.

Background

Medication delivery devices, such as injectors, autoinjectors, and inhalers, typically comprise a housing in which a medication container containing a medication is to be disposed. After activation of the drug delivery device, the drug is ejected through a drug delivery member, such as a needle or nozzle.

In injection devices where the drug delivery member is a needle, the needle is shielded and remains sterile. Therefore, the drug delivery member may be provided with a delivery member shield or cover, such as a Flexible Needle Shield (FNS) or a Rigid Needle Shield (RNS). . The delivery member shield may thus be attached to the drug container to cover the drug delivery member.

More specifically, auto-injectors typically comprise a drive mechanism for exerting a force to expel the drug from the drug container through the drug delivery member, a trigger member engageable with the drive mechanism to release the drive mechanism for expelling the medicament, and a plug connected to the front end of the housing for removing the shield from the delivery member. Some autoinjectors, as described in document WO2014131858 A1, also comprise a mechanical interlock that prevents actuation of the activation member before the cap is removed so that when the cap is removed, the mechanical interlock then allows actuation of the activation member. .

Furthermore, EP2745866A1 also discloses an autoinjector comprising a housing for containing a syringe with a needle, a force mechanism for applying a force to eject a liquid medicament from the syringe, a deflected needle cover sleeve coupled to the force mechanism to release the force mechanism to cause an injection and having a flexible arm, a needle guard that covers the needle, a plug connected to the front end of the housing for removing the needle guard. When the stopper is attached to the housing, the needle cover sleeve is partially moved into the housing so that the flexible arm is biased by a surface of the stopper and held in the biased state by a surface of the housing so that actuation of the needle cover sleeve is prevented before the cap is removed. When the plug is removed, the needle cover partially moves out of the housing so that the flexible arm does not interact with the housing and allows actuation of the needle cover sleeve.

Summary

In view of the known prior art, it is seen that a removable plug unit has the function of providing mechanical protection to the drug delivery member while it is attached to the housing and of removing the protection from the delivery member when part of the plug unit. leaves the accommodation. However, there is a tangible risk that the activation mechanism of the drug delivery device may be influenced by any accidental or deliberate movement of the activation member during transportation or by accidentally dropping the drug delivery device, among others. things.

Therefore, it is a general object of the present description to provide a drug delivery device having a simple and strong cap unit having a common feature in the form of an integrity lock that prevents the drug delivery device from becoming damaged. accidentally activate and also prevent recapping, giving an indication to the user that the device has been used or that the sterility of the drug delivery member has been compromised.

Therefore, according to a first aspect of the present description, there is provided a drug delivery device according to the features of the present claims 1-17.

Brief description of the figures

Specific embodiments of the present inventive concept will now be described, by way of example, with reference to the accompanying figures, in which:

Figure 1 illustrates a perspective view along the longitudinal axis L of the cap unit of the drug delivery device according to a first embodiment of the present invention.

Figure 2 shows an exploded perspective view of the embodiment described in Figure 1, where its parts are illustrated in greater detail.

Figure 3 shows side views of selected components of the Figure 1 embodiment: the tubular plug body (Figures 3a, 3b), the housing (Figure 3c), and the closest plug (Figure 3d).

Figure 4 shows side views of two main components of the Figure 1 embodiment: the integration blocking member (Figures 4a, 4b, 4c) and the activation member (Figure 4d).

Figure 5 illustrates a cross-sectional perspective view of the interior parts of the embodiment of Figure 1, in particular the deshielder connected to the medicament container.

Figure 6 illustrates a closer view of the first and second positions (Figure 6a and Figure 6b) in the first embodiment of Figure 1.

Figure 7 shows the drug delivery device in the "cap off" position, when the removable cap unit is fully removed by the user.

Figure 8 represents a second embodiment of the invention along the longitudinal axis L.

Figure 9 shows an exploded view of the second embodiment described by Figure 7, notably with the lack of a second attachment structure on the tubular housing compared to the first embodiment of Figure 1. Figure 10 shows side views of the components of the second embodiment of Figure 8, namely the plug lock (Figure 10a, Figure 10b) and the integration lock member (Figure 10c, Figure 10d) describing minor changes compared to the first embodiment from Figure 1

Figure 11 illustrates in two different positions (Figure 11a, Figure 11b) a first position and a second position similar to the first embodiment.

Figure 12 shows transparent views of the proximal portion of the drug delivery device in sequence from the first position to the second position.

Detailed description

There will now be described, with reference to Figures 1 to 10 of the accompanying drawings, according to the device of the present invention.

In the present application, when the term "distal part/end" is used, it refers to the part/end of the delivery device, or the parts/ends of its members, that is/are furthest from the delivery site of patient medication. Correspondingly, when the term "proximal part/end" is used, it refers to the part/end of the delivery device, or the parts/ends of its members, that is/are closest to the drug delivery site of the device. patient.

Parts of a drug delivery device according to the present invention are illustrated in Figure 1. A housing 2 is shown having a proximal end and a distal end. Housing 2 extends along a longitudinal axis L. Also shown is a removable cap unit 10 and medicament container 8 .

Figure 2 illustrates an exploded view of a preferred embodiment of the invention according to Figure 1. The figure illustrates a more detailed view of the removable plug unit 10 comprising a closer plug 5 (Figure 2.f), a body 7 an outer tubular plug (Figure 2.a) and an inner tubular integrity locking member 9 (Figure 2.b). It also illustrates a tubular housing 2 (Figure 2.c) and an activation member 3 (Figure 2.d). Both the tubular housing 2 and the activation member 3 are parts of the drug delivery device and the cap unit.

In addition, it also illustrates a deprotector 4 connected to a drug container 8 (Figure 2.e).

The outer tubular plug body 7 (Figure 2.a) is removably connected to the tubular housing 2 along the axis L as previously shown in Figure 1. In addition, the outer tubular plug body 7 comprises members gripping 75 on its outer surface (also visible in Figure 1), and a transverse wall 72 having an opening channel 71 to allow the distal part of the deprotector 4 to pass through during assembly. The gripping members 75 facilitate an improved grip by a user's fingers/hands on the outer tubular plug body 7 .

The inner tubular integrity locking member 9 (Figure 2.b) is coaxially coupled to the outer tubular plug body 7 at its proximal portion for the purpose of facilitating assembly. The transverse wall 72 of the outer tubular plug body 7 comprises a pair of spaced and opposite openings 73a and where each opening 73a is configured to receive a snap-fit member 51 of the nearest plug 5 (Figure 2.f) and, thus, fixedly connect the outer tubular plug body 7 and the nearest plug 5.

Activation member 3 (Figure 2.d) is operatively connected to a drug delivery device mechanism (not shown) that is associated with the drug container, and said activation member 3 is longitudinally movable relative to the tubular housing 2 from an extended position to a retracted position to activate the drug delivery mechanism. In the extended position, a proximal portion of the activation member 3 extends from the proximal end of the housing 2 and in the retracted position most of the proximal portion of the activation member 3 is covered by the tubular housing 2 or the surface of proximal end of activation member 3 is flush with the proximal end surface of housing 2.

Figure 3 shows in greater detail the body 7 of the tubular cap (Figure 3.a), a side view of the transverse wall 72 of the body 7 of the tubular cap (Figure 3.b), the tubular housing 2 (Figure 3.c ) and the view of the inner face of the closest plug 5 (Figure 3.d) according to the embodiment of Figure 1.

The outer tubular plug body 7 (Figure 3.a) also comprises at its distal end a distal rim 76 and a receiving tab portion 78 which is part of the distal rim 76.

The transverse wall 72 of the tubular stopper body 7 (Figure 3.b) comprises: the opening channel 71 and four radial openings 73, 74. The two opposite openings (73a, 73b) (73b shown in Figure 3.b) they are respectively attached to the snap-fit members 51 of the nearest plug 5 securing the nearest plug 5 to the tubular plug body 7 . On the contrary, the other two opposite openings (74a, 74b) (74b not shown in Figure 3.b) are attached in the same way to the wings 98 of the inner tubular integrity locking member 9 (Figure 4.b) to fix the integral locking member 9 to the tubular plug body 7 .

The end 29 of the distal part of the tubular housing 2 (Figure 3.c) comprises an annular collar 27. The annular collar 27 of the housing 2 comprises a proximal radial edge 26 with two proximal extensions in the form of two semicircular tabs 28 on opposite sides of the tubular housing 2, which intersect respectively with the receiving portions 78 of the body 7 of the outer tubular plug. Alternatively, the annular collar 27 of the housing 2 may comprise cavities which intersect respectively with tabs of the outer tubular plug body 7 .

The proximal part of the tubular housing 2 comprises a proximal rim 25 with two second opposing joining structures 21 . Each second attachment structure 21 is formed as a U-shaped slot or cutout 20 which, in turn, is defined by a transverse edge 23 and two opposite and spaced lateral edges 24. Each lateral edge 24 forms an inward transverse projection that has an edge 22 and where said edge 22 forms part of the proximal edge 25 of the tubular housing 2

The proximal side of the nearest plug 5 is illustrated in Figure 2.f, thus a distal view or opposite side of the nearest plug is required (Figure 3.d). As can be seen, a leg elevation 52 "H" of the nearest cap 5 is cut into the channel opening 71 of the transverse wall 72 of the tubular cap body 7 . The closest stopper 5 also comprises an inner circular projection 53, the function of which will be explained later.

Figure 4 shows the integration locking member 9 in a perspective proximal view (Figure 4.a), a corresponding distal view (Figure 4.b) and its side view (Figure 4.c). Furthermore, a perspective view of the activation member 3 is provided (Figure 4.d).

The inner tubular integrity locking member 9 (Figure 4.a) comprises at a distal end a distal rim 99 and a resilient structure 91, which is formed by a pair of spaced apart longitudinally extending arms 92 extending distally from a U-shaped cut-out portion. The pair of spaced longitudinally extending arms 92 extend a certain distance from the distal rim 99 of the inner tubular integrity locking member 9 and said extending arms 92 run distally as two free ends 94 distal. In addition, the spaced longitudinally extending arms 92 are flexible in the transverse direction and define a central opening or cutout 93 therebetween.

As seen in Figure 4.b, each longitudinally extending arm 92 extends radially inwardly from the inner surface of the inner tubular integrity locking member 9 and can be seen as an inner rib or elevation 90. In addition, each end 94 free distal has a first transverse lip 95 that is extends inward, a second transverse lip 96 that extends outward, and a distal upper edge 97 (FIG. 4.c).

The proximal portion of the activation member 3 has two opposite radial outer surfaces (Figure 4.d), each surface forming a first attachment structure 31 . The first joint structure 31 comprises a guide recess and a guide projection 33. The guide recess is U-shaped and is defined by two longitudinally extending parallel side walls 32, a transverse side wall 34 and a bottom wall 35. The guide projection 33 is disposed on the outer surface of the bottom wall 35 of the guide recess.

Furthermore, the activation member 3 comprises a transverse wall 38 at its proximal end and has an opening channel 36 to allow the deprotector 4 to pass through.

Figure 4.d also shows two opposite and spaced apart wings 37 extending from the distal rim of the distal end of the activation member 3. Said opposing wings 37 may be configured to interact with the drug delivery mechanism (not shown) of the drug delivery device.

Each outwardly extending second transverse lip 96 has a shape configured to interact with a corresponding shape formed in each side edge 24 of the U-shaped slot or cutout 20 of the housing 2 to allow a distal portion of each arm 92 to longitudinally extending bends transversely inwardly and each inwardly extending transverse first lip 95 has a shape configured to interact with a corresponding shape of the guide projection 33 disposed in the bottom wall 35 of the guide recess to allow the arm 92 to extending longitudinally bends transversely outwardly when the inner tubular integrity locking member 9 is displaced proximally a certain distance relative to the housing 2 and to the activation member 3.

Figure 5 illustrates a side view, a cross-sectional view and an exploded view (Figure 5.c) of the deshielder 4 connected to a drug delivery member protector 6 via connecting members 41 (Figure 5.a) . The drug delivery member shield 6 in the present first embodiment is shown as a Rigid Needle Shield (RNS), but it can also be a Flexible Needle Shield (RNS) (Figure 5. b). The FNS is connected to the drug container 8 to protect a drug delivery member which in the present embodiment is shown as a needle. The stripper 4 comprises a proximal end portion with a radially outwardly extending rim 42. This rim 42 is configured to be positioned between the inner circular projection 53 of the nearest cap 5 and the transverse wall 72 of the outer tubular cap body 7, so as to be fixedly attached to the outer tubular cap body 7.

In Figure 6, side views of the proximal portion of the removable plug unit 10 (Figure 6.a and Figure 6.b) in a first and second position can be seen particularly for the first embodiment according to Figure 1.

Removable plug unit 10 is configured to move proximally relative to housing 2 and relative to activation member 3 from a first position to a second position. In the first position (Figure 6.a) of the removable plug unit 10, the resilient structure 91 of the inner tubular integrity locking member 9 is removably attached in a cavity defined by a portion of the first attachment structure 31 of the activation member 3 and a portion of the second attachment structure 21 of the housing 2 to prevent the activation member 3 from moving towards the retracted position.

Thus, when the removable plug unit 10 is in the first position (FIG. 6.a), the pair of spaced-apart longitudinally extending arms 92 extend longitudinally along the bottom wall 35 of the shaped guide recess. and receive the guide projection 33, disposed on the bottom wall 35 of the U-shaped guide recess, in the opening 93 defined by the pair of spaced-apart longitudinally extending arms 92, and each second transverse lip 96 extending outwardly extending releasably engages the corresponding side edge 24 of the U-shaped slot or cutout 20 of the housing 2 to prevent the longitudinally extending arms 92 from bending transversely outwardly. Furthermore, when the removable plug unit 10 is in the first position, the proximal rim 25 of the housing 2 bears against the distal rim 99 of the inner tubular integrity locking member 9 and the proximal radial rim 26 of the housing 2 bears against. the distal rim 76 of the tubular plug body 7 . Furthermore, when the removable cap unit 10 is in the first position, the drug delivery member protector 6, i.e., the RNS, is attached to the drug container 8, i.e., a syringe, and thereby maintaining , the sterility of the drug delivery member, ie, the needle, and the connection members 41 of the deprotector 4 are connected to the RNS.

According to Figure 7, the user manually extracts the outer tubular plug body 7 along the axis L. Said movement separates the removable plug unit 10 from the tubular housing 2 and the activation member 3. At the same time, the deshielder 4, together with the medicament delivery member protector 6, is detached from the syringe body 8 and exposes the delivery member 6, ie the needle which is surrounded by the activation member 3. Separation of the removable plug unit 10 from the tubular housing 2 and activation member 3 occurs when the free ends 94 of the longitudinally extending arms 92 are released from the cavity formed by the first 31 and second 21 linking structure portions due to the flexibility of the free ends 94 of the longitudinally extending arms 92.

Furthermore, when the removable plug unit 10 is in the second position (Figure 6.b), the pair of spaced longitudinally extending arms 92 extend longitudinally along the bottom wall 35 of the U-shaped guide recess. and each inwardly extending first transverse lip 95 abuts against guide projection 33, and each upper distal edge 97 of arms 92 abuts against edge 22 of proximal rim 25 of housing 2 to prevent the plug unit from removable to move to the first position, i.e. to be covered again. Furthermore, when the removable plug unit 10 is in the second position, the proximal rim 25 of the housing 2 is positioned at a distance from the distal rim 99 of the inner tubular integrity locking member 9 and the proximal radial edge 26 of the housing 2 it is positioned at a certain distance from the distal rim 76 of the tubular plug body 7 . Furthermore, when the removable plug unit 10 is in the second position, the drug delivery member shield 6, i.e., the RNS, has moved distally a certain distance relative to the drug container 8, i.e., a syringe, and the connection members 41 of the deprotector 4 are still connected to the RNS. The cavity formed by the portions of the second 21 and first 31 connecting structures is therefore unreachable by the free ends 94 of the extending arms 92 . Since the removable plug unit 10 is prevented from moving into the first position (Figure 6.b), the distance between the proximal radial edge 26 of the tubular housing 2 and the distal rim 76 of the tubular plug body 7 gives an indication to a user that the sterility of the drug delivery member, ie, the needle, has been compromised and/or that the device has been used. Provides an indication of tamper-proofing to the user.

Figure 8 illustrates, in perspective, parts of a drug delivery device 1 of the invention along the longitudinal axis L in a second embodiment of the drug delivery device 1 of the invention. Although the tubular plug body 7a (not shown in Figure 8) lacks the gripping members 75, these can still be implemented as an alternative feature.

Figure 9 illustrates an exploded view of the second embodiment of the invention according to Figure 8. Figure 10 illustrates a more detailed view of the key parts of the device similar to Figure 2. Although the parts are similar in both embodiments, there are some minor differences in the second embodiment, namely: the tubular housing 2a, the closest plug 5a, the outer tubular plug body 7a and the inner tubular integrity locking member 9a

Figure 10 shows in greater detail the perspective views of the closest plug 5a (Figure 10.a and Figure 10.b) and of the inner tubular integrity locking member 9a (Figure 10.c and Figure 10.d), according to the second embodiment of Figure 8.

The closest stopper 5a can be opened or closed depending on the mounting needs of the drug delivery device 1. In the second embodiment (FIG. 10.a), the closest plug 5a comprises a transverse wall 56 having an opening channel 54, snap-fit members 51 and longitudinally extending wall portions 59. Snap-fit members 51 and longitudinally extending wall portions 59 extend distally from transverse wall 56. Closer plug 5a also comprises receiving tab portions 55 disposed between longitudinally extending wall portions 59 ( Figure 10.b). The longitudinally extending wall portions 59 intersect the inner surface at the proximal portion of the outer tubular plug body 7a.

As can be seen (Figure 9 and Figure 10.c), the inner tubular integrity locking member 9a has been slightly modified. The inner tubular integrity locking member 9a comprises a transverse wall 102 having a through opening 104 and longitudinally extending tubular walls 105 having spaced apart and opposing cuts. Longitudinally extending tubular walls 105 and spaced and opposite longitudinally extending arms 92a (not shown in Figure 10.c) extend distally from transverse wall 102 and are radially offset from each other, wherein spaced and opposite arms 92a opposite longitudinally extending arms are closer to axis L. The spaced arms 92a are flexible in the transverse direction and define a central opening or cutout 93a therebetween similar to that of the first embodiment. Each of the longitudinally extending arms 92a of the inner tubular integrity locking member 9a (FIG. 10.c) is further provided with a distal free end 94a having a first inwardly extending transverse lip 95a and an inwardly extending transverse lip 95a. upper distal edge 97a. However, the distal rim 99a of the distal end of the integrity locking member 9a has been extended such that there is some distance between the upper distal edges 97a of the longitudinally extending arms 92a and the distal rim 99a of the distal end 9a of the integrity lock member. integrity lock member. Therefore, the resilient structure 91a still comprises the pair of longitudinally extending spaced-apart arms 92a and the distal rim 99a. This resilient structure 91a of the inner tubular integrity locking member 9a has been modified for improved cooperation with the first attachment structure 31 of the activation member 3 and the second attachment structure 21a of the housing 2.

The proximal end of inner tubular integrity locking member 9a includes two equal side wings 98a that extend proximally from transverse wall 102 (FIG. 10.d). Each fin 98a comprises a snap-fit member configured to connect to a corresponding second opening 74a, 74b in the transverse wall 72 of the tubular plug body 7a. Furthermore, each wing 98 enlarges toward the proximal end forming a first outer shoulder 100. In addition, each wing 98 is provided with a second outer shoulder 101 having a distally sloped surface and a proximal stepped surface. The fins 98a of the inner tubular integrity locking member 9a pass through the second openings 74a, 74b of the transverse wall 72 of the tubular plug body 7a so that the inner tubular integrity locking member 9a can move longitudinally within a certain distance in relation to the tubular plug body 7a.

In Figure 11 side views of the first and second position of the removable plug unit 10 can be seen.

As mentioned above, the activation member 3 can move longitudinally relative to the tubular housing 2 from an extended position to a retracted position to activate the drug delivery mechanism 1. In the extended position, a proximal portion of the activation member 3 extends from the proximal end of the housing 2 and in the retracted position most of the proximal portion of the activation member 3 is covered by the tubular housing 2 or the surface of proximal end of activation member 3 is aligned with the proximal end surface of housing 2a.

In a first position of the removable plug unit 10, the resilient structure 91a of the inner tubular integrity locking member 9a is attached to a first attachment structure 31 of the activation member 3 and to a second attachment structure 21a of the housing 2 for prevent the activation member 3 from moving towards the retracted position in case the device is accidentally dropped or activated during transport.

More particularly, in the first position of the removable plug unit (FIG. 11a), the free ends 94a of the extended arms 92a are removably held in a cavity defined by a portion of the first attachment structure 31 and the second attachment structure 31 . junction 21a, wherein the upper distal edges 97a of the longitudinally extending arms 92a bear against the transverse side wall 34 and are located at a distance from the second junction structure 21a which in the second embodiment is the proximal rim of accommodation 2a. Furthermore, in the first position (FIG. 11a), the second attachment structure 21a of the housing 2a also bears against the distal rim 99a of the inner tubular integrity locking member 9a. Furthermore, the pair of spaced-apart longitudinally extending arms 92a extend longitudinally over the bottom wall 35 of the U-shaped guide recess and receive the guide projection 33, which is disposed on the bottom wall 35 of the U-shaped guide recess. of U of activation member 3, in the opening 93a defined by the pair of spaced apart longitudinally extending arms 92a and the first transverse inwardly extending lips 95a. Furthermore, in the first position of the removable plug unit 10, each proximal portion of the wings 98a of the integrity locking member 9a is positioned in a corresponding receiving tab portion 55 of the nearest plug 5 such that the proximal portion of fins 98 can move radially inwards relative to the nearest plug 5; and each distally inclined surface of the second outer projections 101 of the wings 98a of the integrity locking member 9a abuts against a corresponding surface surrounding the opening 74 of the transverse wall 72 of the tubular plug body 7a. Furthermore, the first outer projection 100 and the rim 42 of the stripper 4 are positioned at a certain distance from the transverse wall 72 of the tubular plug body 7a.

The user manually extracts the proximal portion of the drug delivery device 1 by manipulating the outer tubular plug body 7a along the axis L similarly to the first embodiment. Said movement separates the removable plug unit 10 from the tubular housing 2a and from the activation member 3. At the same time, the deshielder 4, together with the medicament delivery member protector 6, is detached from the syringe body 8 and exposes the delivery member 6, ie the needle which is surrounded by the activation member 3.

The separation occurs in several stages, from the first position (Figure 11a) to a second position (Figure 11b):

- The outer tubular plug body 7a together with the closest plug 5a hardly moves in relation to the inner tubular integrity locking member 9a and with the housing 2a along the axis L towards the proximal end, where the surfaces that surround openings 74 in transverse wall 72 of tubular plug body 7a interact with distal sloped surfaces of second outer projections 101 of fins 98a of integrity locking member 9 such that fins 98 bend radially inward and then After the surfaces surrounding the openings 74 in the transverse wall 72 have passed the distally sloped surfaces of the second outer projections 101, the flaps 98 fold back to their original position.

- The outer tubular plug body 7a together with the closest plug 5a is further moved in relation to the inner tubular integrity locking member 9a and with the housing 2a along the axis L towards the proximal end until the first protrusion outer 100 bears against the transverse wall 72 of the tubular plug body 7a. At this stage, the rim 42 of the stripper 4 also bears against the transverse wall 72 of the outer tubular plug body 7a.

- Integrity locking member 9a, deprotector 4 and drug delivery member protector 6 together with outer tubular plug body 7a can now move relative to housing 2a towards the proximal end where free ends 94a The distal ends of the longitudinally extending arms 92a extend past the shoulder 33 when slid against the bottom wall 35 and the edges of the shoulder 33 of the activation member 3, so that the distal free ends 94a of the longitudinally extending arms 92a are released from the cavity formed by the attachment structure 31 of the activation member 3 and the second attachment structure 21a.

At this stage, the user may attempt to recap the removable plug unit 10 by moving the outer tubular plug body 7a relative to the housing 2a towards the distal end. After performing this movement, the removable plug unit 10 is (Figure 11.b) in the second position where the pair of spaced apart longitudinally extending arms 92a extend longitudinally over the bottom wall 35 of the guide recess. U and each upper distal edge 97a of the arms 92a bears against a stepped surface of the guide projection 33 of the activation member 3 wherein the activation member 3 moves a certain distance towards the distal end relative to the housing 2a until that the distal rim 99a of the distal end of the integrity locking member 9a abuts against the second attachment member 21a of the housing 2a. Movement of the activation member 3 towards the distal end does not activate the activation mechanism. Furthermore, the surfaces surrounding the openings 74 of the transverse wall 72 of the tubular plug body 7 abut against the proximal stepped surfaces of the second outer projections 101. Therefore, the removable plug unit 10 is prevented from moving forward. the first position, that is, it is covered again.

The removable plug unit 10 of the second embodiment of Figure 8 can be seen in four sequential stages in Figure 12. The purpose of this figure is to illustrate the movement of the wings 98a over the proximal portion and the plug-receiving tab portion 78 . removable cap unit 10.

The first position (Figure 12.a) shows the second outer protrusion 101 attached to the opening 74, while the first outer protrusion 100 is positioned on the nearest cap receiving tab portion 55 5a. The tubular housing 2a is attached to the outer tubular plug body 7a by connecting the tab 78 to the tab 28. Figure 12.b shows the second outer projection 101 slightly released from the opening 74, while the first projection exterior 100 is partially free from the receiving tab portion 55 of the nearest cap 5a. The outer tubular plug body 7a is loosely loosened from the tubular housing 2a; therefore, a space is formed between the connection of the tongue 78 and the tongue 28. In Figure 12.c the second position is illustrated when the second outer projection 101 is completely free of the opening 74. In Figure 12. d is illustrated when the user attempts to recap. The second outer projection 101 interacts with the opening 74 and prevents the outer plug body 7a from moving back to the first position.

The inventive concept has been described primarily with reference to the two detailed embodiments. However, as any person skilled in the art will readily appreciate, there are other embodiments in addition to those described above and that are equally possible within the scope of the inventive concept, as defined in the appended claims.

Claims (1)

i. A drug delivery device (i) comprising: - a housing (2; 2a) having a proximal end and a distal end; - a medicament container (8) placed in the housing (2; 2a) and having a medicament delivery member protector (6); - a medication supply mechanism associated with the medication container (8); - an activation member (3) operatively connected to the drug delivery mechanism and longitudinally movable relative to the housing from an extended position to a retracted position to activate the drug delivery mechanism; Y - a removable plug unit (10) comprising an outer tubular plug body (7; 7a) and an inner tubular integrity locking member (9; 9a) coaxially coupled to the outer tubular plug body; characterized in that in a first position of the removable plug unit (10), a resilient structure (91; 91a) of the inner tubular integrity locking member (9; 9a) is configured to interact with both a first structure (31) attachment of the activation member (3) as with a second attachment structure (21; 21a) of the housing (2; 2a) to prevent the activation member (3) from moving towards the retracted position; wherein the resilient structure (91; 91a) of the inner tubular integrity locking member (9; 9a) comprises a pair of spaced longitudinally extending arms (92; 92a) that are flexible in the transverse direction and that define an opening (93; 93a) with each other. The drug delivery device (10) according to claim 1, wherein in a second position of the removable cap unit (10), the resilient structure (91; 91a) of the cap locking member (9; 9a) inner tubular integrity is configured to interact with the second attachment structure (21; 21a) of the housing (2; 2a) to prevent the removable plug unit (10) from moving into the first position. 3. The drug delivery device (10) according to any of claims 1-2, wherein the first attachment structure (31) of the activation member (3) comprises a guide recess (32, 34, 35) and a guide projection (33); and wherein the guide recess (32, 34, 35) is U-shaped and defined by two longitudinally extending parallel side walls (32), a transverse side wall (34) and a bottom wall (35) and in wherein the guide projection (33) is arranged on the outer surface of the bottom wall (35) of the guide recess. 4. The drug delivery device (10) according to claim 1, wherein each arm (92; 92a) extending longitudinally has a free distal end (94; 94a) having a transverse inwardly extending first lip (95; 95a) and an upper distal edge (97; 97a). The drug delivery device of claim 4, wherein the first inwardly extending transverse lip (95; 95a) has a shape configured to interact with a corresponding shape of the guide projection (33) to allow the longitudinally extending arm (92; 92a) bends. The drug delivery device (10) according to claims 1-5, wherein in the first position of the removable cap unit (10), the pair of spaced apart longitudinally extending arms (92; 92a) is configured to extend longitudinally along the bottom wall (35) of the U-shaped guide recess (32, 34, 35) and to receive the guide projection (33) in an opening (93) defined by the pair of arms (92) spaced apart extending longitudinally. 7. The drug delivery device (10) according to claims 1-6, wherein the second attachment structure (21) is formed as a U-shaped slot or cutout (20) defined by a transverse edge (23) and two separate and opposite lateral edges (24) and where each lateral edge (24) forms an inward transverse projection having an edge (22) that forms part of a proximal edge (25) of the tubular housing (2). The drug delivery device (10) of claims 4-7, wherein each free distal end (94) further comprises a second outwardly extending transverse lip (96) releasably connecting to a corresponding side edge (24) of the U-shaped slot or cutout (20) in the housing (2) to prevent the longitudinally extending arms (92) from bending transversely outward and thus prevent the member (3) from activation mechanism moves to the retracted position when the removable plug unit (10) is in the first position. 9. The drug delivery device (10) of claims 2-8, wherein when the removable cap unit (10) is in the second position, the pair of spaced longitudinally extending arms (92) extend longitudinally along the bottom wall (35) of the recess (32, 34, 35) of U-shaped guide and each inwardly extending first transverse lip (95) bears against the projection (33), and each distal upper edge (97) of the arms (92) is rests against the edge (22) to prevent the removable plug unit (10) from moving into the first position. 10. The drug delivery device (10) according to claim 7, wherein the second attachment structure (21a) is the proximal rim of the housing (2a). 11. The drug delivery device (10) according to claims 4-10, wherein in the first position of the removable plug unit (10), the free ends (94a) of the extending arms (92a) are removably secured in a cavity defined by a portion of the first attachment frame (31) and the second attachment frame (21a), wherein the upper distal edges (97a) abut against the transverse sidewall (34) and are located at a distance from the second attachment structure (21a), and wherein the second attachment structure (21a) abuts against the distal rim (99a) of the inner tubular integrity locking member (9a). The drug delivery device (10) of claim 1, wherein the inner tubular integrity locking member (9a) comprises a flexible snap-fit member or flap (98) having a first projection (100) outer end and a second outer projection (101) along the wing (98) that are configured to longitudinally interact with openings (74a, 74b) in a transverse wall (72) of the outer tubular plug body (7a). 13. The drug delivery device (10) according to any of claims 1-12, wherein the outer tubular plug body (7) and the inner tubular integrity locking member (9) are fixedly or integrally coupled . 14. The drug delivery device (10) according to any claim 1-13, wherein the drug delivery device (10) is an autoinjector.